Mitral cerclage annuloplasty apparatus

ABSTRACT

A mitral cerclage annuloplasty apparatus comprises a tissue protective device and a knot delivery device. The tissue protective device comprises a first protective tube and a second protective tube. The knot delivery device comprises a tube wherein a loose knot is looped around its distal end through a hole and wherein tight knot is formed when the distal end of the tube is cut open. Alternatively, the knot delivery device comprises an inner tube and outer tube. The inner tube is insertable and rotatable inside the outer tube. When the tubes are in a closed position by rotating either the outer tube or the inner tube, a hole is created near its distal end. When the tubes are in open position by rotating either the outer tube or the inner tube, the hole joins the opening of the outer tube and lengthens.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a divisional application for U.S. Ser. No. 12/631,803, filed onDec. 4, 2009 now U.S. Pat. No. 8,231,671, which claims the benefit ofU.S. Provisional Application No. 61/239,828 filed on Sep. 4, 2009 andclaims foreign priority benefit of Korean Patent Application No.10-2009-0080708 filed on Aug. 28, 2009 which is incorporated herein inits entirety.

FIELD OF THE DISCLOSURE

The present disclosure relates to annuloplasty devices and techniques inwhich the coronary sinus and the tricuspid valve are protected fromerosion using a tissue protective device while maintaining appropriatetension by using a knot delivery device.

BACKGROUND OF THE INVENTION

The heart is the center of human circulatory system that pumps bloodthrough our body. It is a muscle that pumps the blood only in onedirection. In order for the heart to effectively keep thisunidirectional flow of blood, it must have properly functional valvesthat prevent back flow through its system, or regurgitation. The heartis divided into four chambers, right and left atria, and right and leftventricles. The four chambers are connected to the aorta, the inferiorand superior vena cavas, the pulmonary artery, and the pulmonary veins.

The mitral valve (“MV”) separates the left atrium from the leftventricle while the tricuspid valve (TV) separates the right atrium fromthe right ventricle. The aortic valve (“AV”) is located between the leftventricle and the aorta while the pulmonary valve (“PV”) is locatedbetween the right ventricle and the pulmonary artery.

Generally, valves should open and close completely with every heart beator contraction. Incomplete opening and closing of the valves causeimproper flow of blood. Valvular diseases are divided into twocategories, regurgitation and stenosis. Regurgitation is a failure ofvalve to close completely and stenosis is a failure of valve to opencompletely.

Mitral valve regurgitation (“MVR”) is a common cardiac valve disorderthat is caused by an incomplete closure of the MV. The MV is locatedbetween the left atrium and the left ventricle. Over time, MVR burdensthe heart and worsens its ability to pump blood properly. Such stress onthe heart will ultimately lead to a heart failure.

Traditional treatment of a worsening MVR requires an open heart surgerywith sternotomy or thoracotomy with cardiac arrest and cardiopulmonarybypass. Once the chest is open and access to the heart is gained, the MVis either repaired or replaced using an artificial valve.

Although very effective, this open-heart procedure is a high risksurgery accompanied by substantial morbidity and prolongedconvalescence. The mortality due to the surgery itself can be as high as5%. As a result, the procedure often is not offered to patients who areinsufficiently symptomatic to justify the surgical risk and morbidity,or to patients with substantial co-morbidity. It is reserved only forthose with severe symptomatic MVR.

This high morbidity rate of an open heart surgery has motivated furtherresearch to develop a safer and less risky alternatives to repair anMVR. Much of the research involves the use of cardiac catheterization.

Recently, this inventor presented a thesis regarding “mitral valvecerclage coronary sinus annuloplasty (MVA)” showing outstanding resultof an MVR treatment through applying circular pressure around the mitralannulus. This thesis has been filed through PCT as an internationalpatent application and published with its publication numberWO2008/060553, which is incorporated herein in its entirety.

The aforementioned thesis and published patent application disclosed themitral cerclage coronary annuloplasty (“MVA”) procedure. Brieflyexplained, a catheter is placed at the coronary sinus after accessingthe right atrium through the jugular vein, and then a cerclage suture ispassed through the proximal septal vein.

This cerclage suture can easily pass through the right ventricularoutflow tract (“RVOT”), and this inventor defines this technique as “thesimple mitral cerclage annuloplasty.” Then the cerclage suture can beeasily pulled into the right atrium thus placing the cerclage suturecircumferentially around the mitral annulus.

Once positioned, tension is applied to the cerclage suture and tightensthe mitral valve. This brings together the two leaflets of the MV, sothat they are approximated and reduce the size of its incompleteclosure. This theory can obtain a very similar result when compared tothe results of a conventional surgery that directly tightens the mitralannulus, and show immediate reduction of an MVR.

However, there are several technical problems to be solved. First, thereis a need to have a tension locking device to be able to apply propertension to the cerclage suture and maintain the tension.

According to the aforementioned research result, approximately 400-1200g tension is needed to have a good treatment result. In addition,individualized tension must be applied constantly until the point wherethe mitral regurgitation is reduced, then, the suture needs to be fixedat that point, so that the same tension is maintained. Further, thistension must be sustained regardless of its constant resistance fromevery beat of each heart contraction.

Since this tension is maintained with a very fine cerclage suture (i.e.,0.014 nylon cerclage used in the researches), it can cause damages onthe neighboring cardiac tissues where the suture contacts and exerts itspressure. Especially, since the cerclage wraps around the tricuspidvalve (TV), it could affect the function of the TV and damage the valveitself and its appendages. This invention is intended to provide viablesolutions to overcome these problems.

SUMMARY OF THE INVENTION

The objective of this invention is to overcome the shortcomings of aconventional MVA. In addition, this invention provides techniques anddevices designed for the MVA to deliver proper, safe, and effectivetension on the cerclage suture.

The other objective is to provide a protective device for tissues, andprevent damage from direct tissue to cerclage suture contact. Inaddition, it provides a knot delivery device (“KDD”) which allows easierway of controlling, adjusting and fixing the tension of the cerclagesuture, so that it can be customized for each individual patient. Itfurther provides a tension locking function in which the fixed cerclagesuture is maintained without becoming loose.

This invention achieves the aforementioned objectives by using anapparatus described here. Generally, the apparatus comprises a tissueprotective device and a knot delivery device.

The tissue protective device comprises a first protective tube and asecond protective tube. The first tube and the second tube each have aproximal portion and a distal portion. The proximal portions of the twotubes are attached side-by-side longitudinally along at least a portionof the length of the two protective tubes. The distal portions of thetwo tubes are separated thereafter.

In a first embodiment, KDD comprises a tube having a proximal end, ahole, and a distal end, wherein a loose knot is looped around the distalend through the hole and wherein a tight knot is formed when the distalend of the tube is cut open.

In a second embodiment, KDD comprises an inner tube and an outer tube.The inner tube and the outer tube each have a proximal end and a distalend. The inner tube is insertable and rotatable inside the outer tube.The distal ends of each tubes have an opening. The opening of the innertube is further divided into a small opening and a large opening.

When the tubes are in a closed position by rotating either the outertube or the inner tube, a hole is created near the distal end. Inaddition, when the tubes are in open position by rotating either theouter tube or the inner tube, the hole joins the opening of the outertube, and lengthens.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a protection device in a particular embodiment, comprisinga coronary sinus tube, a tricuspid valve tube, a hinge portion, a stemportion, a ring-shape stopper, a coronary protection device, and acerclage suture.

FIG. 2 is a schematic view of a cross-sectional top view of the heart,taken at the level of the atrioventricular valves, showing theprotective device in place.

FIG. 3 is a front view of the heart with portions of the myocardial wallremoved to show the protective device in place.

FIG. 4 is a set of drawings showing a knot delivery device (“KDD”) in afirst embodiment using one tube configuration.

FIG. 4(a) shows KDD whose distal end has a hole in a closed positionwhere a loose knot is looped around the distal end through the hole.

FIG. 4(b) shows the distal end of the tube is cut off in open positionwhere a tight knot is formed.

FIG. 5 is a set of drawings showing detailed steps of KDD operation in afirst embodiment.

FIG. 5(a) shows a step of making a loose knot around the distal end ofKDD through the hole using a cerclage suture.

FIG. 5(b) shows a step of tension adjustment where the suture can bepulled or released until the mitral regurgitation stops.

FIG. 5(c) shows a step of cutting off (or opening) the hole, so that theloose knot is ready to form a tight knot.

FIG. 5(d) shows a step of tightening the knot while maintaining theright amount of tension on the cerclage suture.

FIG. 5(e) shows a step of cutting off the cerclage suture.

FIG. 5(f) shows the final step of the cerclage procedure.

FIG. 6 is a set of drawings showing a detailed operation of KDD in asecond embodiment using an inner tube and an outer tube.

FIG. 6(a) shows KDD in a closed position where a hole is created nearthe distal end of KDD by rotating either the outer tube or the innertube, so that a loose knot is formed around the distal end of KDDthrough the hole using a cerclage suture.

FIG. 6(b) shows KDD in an open position where an opening is created nearthe distal end of KDD by rotating either the outer tube or the innertube, so that a loose knot is ready to form a tight knot without cuttingin a step shown in FIG. 4(a).

DETAILED DESCRIPTION OF THE INVENTION

The detailed disclosure of the mitral valve cerclage coronary sinusannuloplasty (“MVA”) comprising of a coronary sinus and tricuspid valveprotective device (“CSTVPD”), and a knot delivery device (“KDD”) will bediscussed.

According to FIGS. 1-3, CSTVPD 20 includes a coronary sinus tube 22 (“CStube”), a tricuspid valve tube 24 (“TV tube”), and a stem portion 26. CStube 22 encircles the coronary sinus (“CS”), and TV tube 24 encirclesthe tricuspid valve (“TV”). Then, extensions of CS tube 22 and TV tube24 meet and run together to form the stem portion 26.

Generally, conventional MVA techniques cause tissue damage (erosion) tothe CS, the TV, and the intraventricular septum (“IVS”) from directcerclage suture to tissue contact. These critical structures can beprotected from damage by using CSTVPD 20 around the cerclage suture.

A part of the CS is protected by a coronary protective device 40 (“CPD”)introduced in the previous MVA thesis. Thus, only the remainder of theCS will need to be protected.

CSTVPD 20 has two separated tubes, CS tube 22 and TV tube 24 whichextend and form the stem portion 26. The thickness of the tubes areapproximately 4 Fr diagnostic catheter made of a flexible rubber or aplastic like material. CSTVPD 20 is named because it protects both theCS and the TV.

In a MVA procedure, first, a cerclage suture is fed through out CSTVPD20 starting at the CS extension of the stem portion 26, CS tube 22, CPD40, TV tube 24, and back out through the TV extension of the stemportion 26, or in reverse direction. Then, the suture-inserted CSTVPD 20is pushed into the body through a catheter and positioned within theheart.

Then, CS tube 22 is positioned to wrap around the CS, and the TV tube 24is positioned to wrap around the TV leaflets. Since the cerclage suture10 is inside the tubes and not in direct contact with the surroundingtissue, the cardiac tissues around the CS, the TV and the IVS areprotected from damage from the cerclage suture 10.

CS tube 22 is a part of a coronary sinus protection device. CS tube 22starts at the orifice of the CS to the beginning of the CPD 40.Anatomically, this length varies from patient to patient. Thus, beforethe procedure, an appropriate length can be determined using anestimation from a CT or other imaging methods. CS tube 22 should be madeof a soft and flexible catheter like material, so that its effect oncompression of the CS is minimized.

TV tube 24 has tapering shape towards its end. Starting from the stopper24 a, the TV tube 24 passes through the muscle of the IVS. Therefore, toease the passing through the IVS muscle, TV tube 24 should taper fromthe stopper 24 a to the end.

In addition, TV tube 24 has a ring-shaped stopper 24 a (RVOT exitstopper 24 a) positioned about mid length of TV tube 24 to preventfurther advancement of TV tube 24 into the heart muscle.

Again, the length of TV tube 24 shall vary from patient to patient. Thelength shall be determined based on the estimation from prior imagingstudies of an individual patient.

Preferably, the length of the TV tube 24 from the hinge portion 27 tothe stopper 24 a shall be derived by actual endocardial surface lengthfrom the ‘RVOT exit’ to the ‘CS opening.’ It should be longer thanactual endocardial surface length to be redundant. This distance fromthe stopper 24 a to the tapered end of the TV tube 24 shall bedetermined by preintervention imaging analysis. Obviously, the locationof the stopper 24 a can vary as needed, and the length from the hingeportion 27 to the stopper 24 a can also vary depending on the need.

The hinge portion 27, where the CS tube 22 and the TV tube 24 meet,shall be placed at or near the orifice of the CS. The TV tube 24 will befixed to the heart at the hinge portion 27 and at the stopper 24 a.Then, the hinge portion 27 to the stopper 24 a portion of the TV tube 24can be suspended freely in a reverse “C” shape without being directlyattached to the tissue. Such technique can reduce the TV tissue damageresulting from direct contact of the cerclage suture, and it alsoreduces the restriction of cerclage on movement of the TV leaflets.

The TV tube 24 shall be rigid enough to resist being bent as tension isapplied onto the cerclage suture. On the other hand, it shall beflexible enough to bend in the reverse “C” shape.

The stem portion 26 plays two roles. First, it stabilizes the CS tube 22and the TV tube 24, so that their position is well maintained. Second,since the hinge portion 27 rests on the orifice of the CS, it preventsfurther advancement of the CSTVPD 20 into the CS. The stem portion 26(where the CS tube 22 and the TV tube 24 are adjoined) should be made ofa semi-rigid catheter like material.

FIG. 4 shows a knot delivery device 30 (“KDD”) in a first embodiment.KDD 30 is designed to transfer the cerclage suture 10 looped and readyto be knotted to the upper portion of the CSTVPD 20 while maintaining aconstant tension on the cerclage suture.

Once positioned and appropriate tension is verified, the KDD 30 willrelease the loop and knot the suture in place, thus, ensuring the knotis positioned in the right place with an appropriate amount of tension.

One of the most crucial component of an MVA procedure is having a devicethat can deliver and maintain necessary tension enough to applycompression on the mitral annulus. That device should be (1) easy tooperate, (2) easy to manipulate cerclage suture tension depending on anindividual patient variance, and (3) easy to readjust and fix tension.Then once cerclage suture is fixed, (4) the suture should not becomeloose and maintain its constant tension well after the procedure.

FIG. 4 is a set of drawings showing the KDD 30 in the first embodimentusing one tube configuration. FIG. 4(a) shows the KDD 30 whose distalend has a hole in a closed position where a loose knot is looped aroundthe distal end through the hole. FIG. 4(a) shows the distal end of thetube is cut off in a closed position where a tight knot is formed. FIG.4(b) shows the distal end of the tube is cut off in an open positionwhere a tight knot is formed.

The KDD 30 is a catheter where a portion 32 of the distal end of the KDD30 can be in a closed position next to a hole 34 where a loose knot islooped around the portion 32 through the hole. The portion 32 is cut offin an opened position where a loose knot becomes a tight knot.

The KDD 30 should be made of a sturdy material often used in diagnosticcatheters. It can be made of rubber or plastic like material strongenough to be pushed inside the body from outside.

As shown in FIG. 4(a) with portion 32 in a closed position, a cerclagesuture 10 is made into a loop ready to be knotted at the distal end ofthe KDD 30. Then, the KDD 30 with the loosely knotted cerclage suture 10is advanced inside the body and positioned appropriately. Then tensionis applied and adjusted. When position and tension is verified, theportion 32 is cut off as in FIG. 4(b), fixing the knot in place whilemaintaining the same amount of tension on the cerclage suture.

FIG. 5 shows detailed steps of The KDD 30 operation. FIG. 5 shows eachsteps of KDD 30 during a MVA procedure.

In summary, FIG. 5 is a set of drawings showing detailed steps of KDD 30operation in a the first embodiment. FIG. 5(a) shows a step of making aloose knot around the distal end of the KDD 30 through the hole 34 usingthe cerclage suture 10. FIG. 5(b) shows a step of tension adjustmentwhere the suture 10 can be pulled or released until the mitralregurgitation stops.

FIG. 5(c) shows a step of cutting off (or opening) hole 34, so that theloose knot is ready to form a tight knot 12. FIG. 5(d) shows a step oftightening the knot while maintaining the right amount of tension on thecerclage suture 10. FIG. 5(e) shows a step of cutting off the cerclagesuture 10. Lastly, FIG. 5(f) shows the final step of the cerclageprocedure.

According to FIG. 5, first, two strands of the cerclage suture 10 areinserted through the hole 34 at the distal end of KDD 30. Second, twostrands are looped and made ready to form a knot 12. Third, the twostrands are passed through the body of KDD 30. Fourth, KDD 30 isadvanced into the heart and positioned at the end of the stem portion 26of CSTVPD 20. Hence, KDD 30 delivers the cerclage suture knot to CSTVPD20 while keeping the knot 12 from tightening until it is ready to befixed.

Then, appropriate amount of tension is applied to the cerclage suture 10and adjusted until the mitral regurgitation ceases. In other words, thetension on the cerclage suture 10 is adjusted by pulling or releasingthe strands until the mitral regurgitation stops.

Once the right amount of tension is achieved, a portion 32 of the KDD 30is cut off from the KDD 30. The portion 32 of the KDD 30 can be cut witha cutter or as explained below in FIG. 4, various methods can beutilized.

When the portion 32 is cut off from the KDD 30, the loop tightens into aknot 12 while maintaining the right amount of tension on the cerclagesuture as shown in FIG. 5(d), so that the end of the cerclage suture isknotted at the distal end of the stem portion 26 of CVTVPD 20. Once theknot 12 is placed and tightened at the end of the stem portion 26, thestem portion 26 can now hold the two strands aligned and in place. Thisalso enables the knot 12 from becoming loose even under a significantamount of tension from the constant beat to beat contraction of theheart.

At this stage, the cerclage suture 10 is cut at a certain distance fromthe knot 12 with a cutter as shown in FIG. 5(e). Then, the remainder ofthe cerclage suture 10 and the KDD 30 is retracted from the body asshown in FIG. 5(f). Thus, upon completion of CSTVPD 20 procedure, CStube 22 and TV tube 24 protects the surrounding tissue from cerclagesuture 10 while maintaining constant tension on the cerclage suture 10.

FIG. 6 is a set of drawings showing detailed operation of the KDD 30 ina second embodiment using an inner tube 38 and an outer tube 36. Theinner tube 38 and the outer tube 36 each have a proximal end and adistal end. The inner tube 38 is insertable and rotatable inside theouter tube 36.

The distal end of the inner tube 38 has an opening 39. The opening 39 isfurther divided into a small opening 39 a and a larger opening 39 b. Thedistal end of the outer tube 36 has an opening 37.

When the tubes 38, 36 are in a closed position by rotating either outertube 36 or inner tube 38, a hole 34 is created near the distal end.Likewise, when the tubes 38, 36 in an opened position by rotating eitherthe outer tube 36 or the inner tube 38, the hole 34 joins the opening 37of the outer tube 36 and lengthens. The outer tube 36 and the inner tube38 are made of a basic catheter type of material.

FIG. 6(a) shows the KDD 30 in a closed position where a hole 34 iscreated near the distal ends of the KDD 30 by rotating either the outertube 36 or the inner tube 38, so that a loose knot is formed around thedistal ends of the KDD 30 through the hole 34 using the cerclage suture10.

FIG. 6(b) shows the KDD 30 in an open position where an opening iscreated near the distal ends of the KDD 30 by rotating either the outertube 36 or the inner tube 38, so that a loose knot is ready to form atight knot 12 without a cutting step shown in FIG. 4(b).

In a preferred embodiment, the inner tube 38 has the small opening 39 awhose length is L1 and whose diameter is d2, and the large opening 39 bwhose length is L2 and whose diameter is d3, wherein the opening 37 inouter tube 36 has a length less than or equal to the sum of L1 and L2-and diameter d1, wherein d3 is larger or equal to the sum of d1 and d2.

While the invention has been described in terms of specific embodiments,it is apparent that other forms could be adopted by one skilled in theart. Accordingly, it should be understood that the invention is notlimited to the specific embodiments illustrated in the Figures. Itshould also be understood that the phraseology and terminology employedabove are for the purpose of disclosing the illustrated embodiments, anddo not necessarily serve as limitations to the scope of the invention.

The invention claimed is:
 1. A set of devices for mitral valveannuloplasty, comprising: a tissue protective device, the tissueprotective device having a cerclage suture disposed within a firstprotective tube and a second protective tube, the first protective tubeand the second protective tube each having a proximal portion and adistal portion, the proximal portions of the two protective tubes beingattached side-by-side longitudinally along at least a portion of thelength of the two protective tubes, the distal portions of the twoprotective tubes being separated thereafter, and a knot delivery devicecomprising an inner tube and an outer tube having a proximal end and adistal end, wherein the inner tube is insertable and rotatable insidethe outer tube, wherein the distal ends of each the inner and outertubes have an opening, wherein the opening of the inner tube is furtherdivided into a small opening and a large opening, wherein when the innerand outer tubes are in a closed position, by rotating either the outertube or the inner tube, a hole is created near the distal end of theknot delivery device, such that the hole forms an overall opening of theknot delivery device, and wherein when the inner and outer tubes are inan open position, by rotating either the outer tube or the inner tube,the hole is part of the overall opening in the knot delivery device withthe opening of the outer tube and the length of the overall opening inthe knot delivery device increases to that of the opening of the innertube, wherein the end of the cerclage suture pass through the hole andthe large opening of the inner tube.
 2. The set of devices according toclaim 1, wherein the tissue protective device further comprises aring-shaped stopper being positioned on the distal portion of the secondprotective tube to prevent further advancement of the second protectivetube into heart muscle.
 3. The set of devices according to claim 1,wherein the distal portion of the second protective tube has a taperingshape towards its end.
 4. The set of devices according to claim 1,wherein the first protective tube is made of flexible rubber or plasticmaterial and has a diameter approximately equivalent to a 4 Frdiagnostic catheter.
 5. The set of devices according to claim 1, whereinthe distal portion of the first protective tube has an archedconfiguration so that the distal portion can be positioned to encircle acoronary sinus.
 6. The set of devices according to claim 1, wherein thesecond protective tube is made of flexible rubber or plastic materialand has a diameter approximately equivalent to a 4 Fr diagnosticcatheter.
 7. The set of devices according to claim 1, wherein the distalportion of the second protective tube is flexible enough to form an archthat encircles a tricuspid valve.
 8. The set of devices according toclaim 1, wherein the distal portion of the second protective tube isrigid enough to resist being bent inward as tension is applied.
 9. Theset of devices according to claim 1, wherein the inner tube has thesmall opening whose length is L1 and diameter is d2, and the largeopening whose length is L2 and diameter is d3, wherein the outer tubehas an opening with a length less than or equal to the sum of L1 and L2,and diameter d1, and wherein d3 is larger or equal to the sum of d1 andd2.
 10. A device for reducing mitral valve regurgitation, comprising: anelongated body comprising a proximal portion and a distal portion, thedistal portion separating into a first arm and a second arm to create ahinge portion, each of the proximal and the distal portions dimensionedto reside completely within the vascular system wherein a cerclagesuture disposed within the elongated body, the first arm, and the secondarm for applying tension, the first arm configured to wrap around amitral valve annulus, the first arm adapted to be delivered into acoronary sinus, the first arm configured to be positioned within thecoronary sinus adjacent the mitral valve annulus, the first armconfigured to have a first arched configuration starting at the hingeportion such that the first arm encircles the coronary sinus as thetension is applied, the second arm configured to wrap around a tricuspidleaflet, the second arm having a stopping element disposed on a distalportion of the second arm, the second arm configured to have a secondarched configuration between the hinge portion and the stopping elementsuch that the second arm resists being bent inward as the tension isapplied, the hinge portion configured to be so positioned at or near acoronary sinus orifice such that the first arm is prevented from furtheradvancement, the hinge portion configured to stabilize the first arm andthe second arm with respect to a heart tissue, the hinge portionconfigured in such a way that the second arm forms an arch from thehinge portion to the stopping element such that the arch is suspendedfreely as the tension is applied.
 11. The device according to claim 10,wherein the distal portion of the second arm is tapered.
 12. The deviceaccording to claim 10, the first arm and the second arm are made of aflexible material.
 13. The device according to claim 10, wherein thefirst arm and the second arm have a diameter approximately equivalent toa 4 Fr diagnostic catheter.
 14. A device for reducing mitral valveregurgitation, comprising: an elongated body comprising a proximalportion and a distal portion, the distal portion separating into a firstarm and a second arm to create a hinge portion, each of the proximal andthe distal portions dimensioned to reside completely within the vascularsystem wherein a cerclage suture disposed within the elongated body, thefirst arm, and the second arm for applying tension, the first arm havingmeans for wrapping around a mitral valve annulus, the second arm havingmeans for wrapping around a tricuspid leaflet, the second arm having astopping element disposed on a distal portion of the second arm, thefirst arm configured to be positioned within a coronary sinus adjacentthe mitral valve annulus, the hinge portion configured to be sopositioned at or near a coronary sinus orifice such that the first armis prevented from further advancement, the second arm having a stopperelement thereon.
 15. The device according to claim 14, wherein thedistal portion of the second arm is tapered.
 16. The device according toclaim 14, the first arm and the second arm are made of a flexiblematerial.
 17. The device according to claim 14, wherein the first armand the second arm have a diameter approximately equivalent to a 4 Frdiagnostic catheter.
 18. The device according to claim 14, wherein thehinge portion is adapted to stabilize the first and the second arms withrespect to a heart tissue.
 19. The device according to claim 14, whereina distal portion of the first arm has an arched configuration so thatthe distal portion is configured to be positioned to encircle thecoronary sinus.
 20. The device according to claim 14, wherein the distalportion of the second arm is rigid enough to resist being bent inward astension is applied.
 21. The device according to claim 14, wherein aportion of the second arm from the hinge portion to the stopper elementforms an arch so that the arch is suspended freely.